Description

The main objective of the trial is to assess the anti-tumor activity of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in post-menopausal patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective is progression-free survival (PFS) as assessed by central review. Defined as time from randomisation until disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) or death from any cause, whichever occurs earlier.

Agree to provide a formalin-fixed paraffin embedded tissue biopsy preferably taken at the time of presentation with recurrent or metastatic disease. Provision of any archival tissue is acceptable, e.g. patients with bone only disease (required)

Satisfy the following criteria for prior therapy (required):

Patient progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor and/or tamoxifen if post-menopausal, or tamoxifen if pre or peri-menopausal, or

Patient progressed while on or within 1 month after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer if post-menopausal, or prior endocrine treatment for advanced/metastatic breast cancer if pre- or peri-menopausal.

Have received more than one previous line of non-steroidal aromatase inhibitor treatment for advanced/metastatic disease. Prior treatment with one line of CDK4/6 inhibitors (allowed)

Had prior treatment with fulvestrant if duration was at least two years in the adjuvant setting or at least six months in the advanced/metastatic setting (allowed)

Are post-menopausal at time of signature of trial informed consent (required)

Have (required):

At least one measurable non-visceral lesion according to RECIST version 1.1 in either lymph nodes, soft tissue, skin and/or

At least one measurable non-visceral lesion according to RECIST version 1.1 as lytic or mixed (lytic + blastic) in bone and/or

At least one non-measurable lytic or mixed (lytic + blastic) bone lesion according to RECIST version 1.1

Have an Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1

Had prior treatment with exemestane (except adjuvant exemestane stopped >12 months prior to start of study treatment as long as the patient did not recur during or within 12 months after the end of adjuvant exemestane)